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TerminatedPhase 3NCT02231164
Official study title

LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research

Study summary

The present trial will investigate the efficacy and safety of nintedanib in combination with docetaxel as compared to placebo in combination with docetaxel in patients with stage IIIB/IV or recurrent NSCLC of adenocarcinoma histology after failure of first-line platinum-based chemotherapy.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studieddocetaxel and docetaxel

Plus 2 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Recurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Feb 13, 2025 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?13 U.S. locations

Locations may change over time.

Who runs it?Boehringer Ingelheim

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Boehringer Ingelheim
Interventions being studied
Drug: docetaxel; Drug: docetaxel; Drug: placebo; Drug: nintedanib
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Disease setting
Recurrent or relapsed→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Male or female patients of at least 18 years of age
  • Histologically confirmed, adenocarcinoma of the lung, after failure of first line platinum-based chemotherapy.
Reasons someone may not be able to joinExclusion criteria
  • More than one prior line of chemotherapy (i.e., 2nd or 3rd line chemotherapy) for advanced and/or metastatic (stage III B or IV NSCLC) or recurrent disease.
  • Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation
  • Previous therapy with other vascular endothelial growth factor (VEGF) or VEGFR inhibitors (other than bevacizumab) or docetaxel for the treatment of NSCLC at any time
  • Prior monotherapy with an EGFR inhibitor except as maintenance therapy

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • 1199.128.10032 Boehringer Ingelheim Investigational SiteChandler, Arizona
  • 1199.128.10041 Boehringer Ingelheim Investigational SiteFayetteville, Arkansas
  • 1199.128.10010 Boehringer Ingelheim Investigational SiteHighland, California
  • 1199.128.10044 Boehringer Ingelheim Investigational SiteRancho Mirage, California
  • 1199.128.10080 Boehringer Ingelheim Investigational SitePaducah, Kentucky
  • 1199.128.10016 Boehringer Ingelheim Investigational SiteFarmington, New Mexico
  • 1199.128.10013 Boehringer Ingelheim Investigational SiteMinot, North Dakota
  • 1199.128.10077 Boehringer Ingelheim Investigational SiteBlacksburg, Virginia
  • 1199.128.10011 Boehringer Ingelheim Investigational SiteKennewick, Washington
  • 1199.128.64006 Boehringer Ingelheim Investigational SiteBatumi
  • 1199.128.64001 Boehringer Ingelheim Investigational SiteTbilisi
  • 1199.128.64002 Boehringer Ingelheim Investigational SiteTbilisi

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Feb 13, 2025. Always confirm current availability with the study team.

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